Bayesian Approaches to Clinical Trials

Dr. Vance W. Berger

Aim of Course:

Today's sophisticated medical research requires more tools than the classic frequentist analysis (null hypothesis vrs. alternative hypothesis). Bayesian methods are seeing increasing use in clinical trials, since they more accurately reflect the "incremental learning from experience" nature of scientific research. This course covers the essentials of Bayesian analysis in randomized clinical trials and the evaluation of medical interventions. We will discuss the distinctions between Bayesian analysis and the more traditional frequentist analysis, and how they relate to medical research. We will pay special attention to the pros and cons of each approach, as well as the scope of applicability of each, and when the two can be used in conjunction with each other.

Who Should Take This Course:

Researchers, analysts, physicians and managers involved with controlled clinical trials.

For those enrolled in a Program of Advanced Statistical Studies, this is a required or elective course in the following Programs:

• Biostatistics (controlled trials) - elective

Course Program:

The course is structured as follows

The Instructor:

Dr. Vance W. Berger is an Adjunct Professor at University of Maryland Baltimore County. He is the author of Selection Bias and Covariate Imbalances in Randomized Clinical Trials (John Wiley and Sons, 2005), and has written or co-written dozens of papers in peer reviewed journals in medicine and statistics. He has also taught in the past at Rutgers University and the Johns Hopkins University School of Public Health, reviews manuscripts for many of the top scholarly journals, has lectured all over the country on his research, and has served as an FDA reviewer for over four years.

Organization of the Course:

The course takes place over the internet, at statistics.com. During each course week, you participate at times of your own choosing - there are no set times when you must be online. Course participants will be given access to a private discussion board. In class discussions led by the instructor, you can post questions, seek clarification, and interact with your fellow students and the instructor. The course is scheduled to take place over 4 weeks, and typically requires 15 hours per week. At the beginning of each week, you receive the relevant material, in addition to answers to exercises from the previous session. During the week, you are expected to go over the course materials and work through exercises. Discussion among participants is encouraged. The instructor will provide answers and comments.

Certificates and Grades:

You may be interested only in learning the material presented, and not be concerned with grades or certificates. Or you may be enrolled in a statistics.com Program in Advanced Statistical Studies that requires demonstration of proficiency in the subject, in which case your work will be assessed for purposes of issuing a grade. Or you may require only a "Certificate of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's). As you begin the class, you will be asked to specify your category.

Credit:

This course offers continuing education units (CEU's). For those successfully completing the course (generally this means marks of 50% or better on the homework), 5.0 CEU's and a certificate will be issued by statistics.com, upon request.

Dates:

Nov. 20 - Dec. 18, 2009
Nov. 19 - Dec. 17, 2010
Click here to be notified of future course offerings.

Participants gain access to the online materials on the first day of the course, and typically spend about 15 hours per week (at their convenience). You retain full access to course materials, including discussion board, for two weeks after the course closing date.

Level:

intermediate/advanced

Prerequisite:

The equivalent of Introduction to Statistics 1: Inference for a Single Variable, and Introduction to Statistics 2: Working with Bivariate Data (and, if necessary before these courses, Introduction to Statistics for Beginners or Survey of Statistics for Beginners). Knowledge of Bayesian methods and the design of clinical trials is also needed.

Course Text:

The required text for this course is Bayesian Approaches to Clinical Trials and Health-Care Evaluation (David J Spiegelhalter, Keith R Abrams, Jonathan P Myles, John Wiley & Sons, 2004) and it can be ordered directly from the publisher by clicking here. Wiley typically offers statistics.com customers up to 15% discount on this book (and all other statistics titles): enter the code aff15 in the Promotion Code field when prompted during checkout and click the Apply Discount button. (If you are located in Asia, the web procedure for your location may not accept this discount -- try calling your regional Wiley representative.) PLEASE ORDER YOUR COPY IN TIME FOR THE COURSE STARTING DATE.

Software:

none

Registration:

Register Online - $469
Register Online (academic) - $369 (you must be affiliated with a college, university or high school)

Add $50 service fee if you require a prior invoice, or if you need to submit a purchase order or voucher, pay by wire transfer or EFT, or refund and reprocess a prior payment. Please use this printed registration form, for these and other special orders.

Consider registering for this course together with two other Clinical Trials courses as part of our special 3 course package registration for tuition savings.

Note: Courses may fill up at any time and registrations are processed in the order in which they are received. Your registration will be confirmed for the first available course date, unless you specify otherwise.